About Edenwell Therapeutics

Edenwell Therapeutics Pvt. Ltd. is an India-based, full-service Clinical Research Organisation incorporated in June 2017. Headquartered in Mumbai (Vikhroli), we are a MSME-registered enterprise that has grown organically from a modest startup into a globally capable CRO, having successfully executed multi-million dollar international clinical trial contracts and navigated complex regulatory environments on behalf of our clients.

We serve pharmaceutical, biotechnology, and medical device sponsors — both domestic and international — offering end-to-end clinical research services that are customised, cost-competitive, and compliant with the highest global standards.

Our Vision

Our vision is to contribute to the global advancement of medical science and serve the society through continuous efforts and improvement in the drug development and clinical research services.

Our Mission

Our mission is to provide customized and advanced strategic solutions to all partners at low costs with highest quality and ethical standards in shortest span of time.

Who are we

After navigating a significant journey since its inception in the year 2017, Edenwell has undoubtedly experienced fruitful outcomes. Focused on our unwavering vision and mission, the company persistently contributes to the global healthcare industry. Highlighted below are key milestones marking the company’s trajectory of consistent growth.

-- OUR JOURNEY --

Our Story — From Startup to Global CRO

2017 — Foundation

Incorporated in Mumbai, Maharashtra, with a lean founding team of CRAs and CTAs. Core infrastructure established; quality management systems aligned with ICH-GCP standards from day one.

2018 — First Contract

Relocated to a dedicated office in Thane West. Successfully completed a quality audit by a leading Indian pharmaceutical company, resulting in the award of our first third-party clinical monitoring services contract.

2019 —Commercial Expansion

Entered a phase of structured growth: expanded our technical workforce, strengthened service delivery capabilities, and established a long-term preferred monitoring partnership with a domestic pharmaceutical client.

2020–2021 — COVID-19 Resilience

Maintained uninterrupted service delivery through the pandemic period. Demonstrated operational agility by rapidly adapting to compliant remote-monitoring and hybrid operational protocols. Sustained revenue growth above pre-pandemic baseline.

2021 — Global Breakthrough

Awarded a landmark multi-million dollar contract with a large international pharmaceutical sponsor for the execution of a global Phase III oncology trial in India. Successfully passed a remote international QA audit; secured DCGI approval; defended protocols at SEC Oncology meetings; obtained Clinical Trial and Import Licence approvals. Revenue classified as export of clinical research services — generating direct foreign exchange inflow into India.

2021–2023 — Diversification & Financial Independence

Concurrently executed Phase IV study support and medical writing/regulatory documentation engagements. Fully repaid all startup liabilities within six months, transitioning to a debt-free, financially independent status.

2024–2026 — Advanced Biologicals & Vaccines

Successfully managed the regulatory roadmap for complex biological products (rFSH and Dengue Vaccine) for a leading Indian multinational pharmaceutical company, demonstrating Edenwell’s capability to handle high-barrier biologicals and vaccines. Progressing toward closure of the global Phase III oncology study while maintaining active business development across India and international markets.

Leadership

Edenwell stands as a pioneering force in the industry, boasting an indisputable track record of excellence in providing end-to-end clinical research services to the pharmaceutical, FMCG, and medical device sectors. However, the foundation of this success lies squarely on the shoulders of Edenwell’s management team — a group comprised of some of the finest industry experts. Their expertise and leadership have been instrumental in realizing and sustaining the company’s commitment to delivering exceptional services across the spectrum of clinical research.

About Us